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Apr 42 min read

USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Feb 171 min read

USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Dec 8, 20221 min read

USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations

Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new...

Nov 1, 20221 min read

USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA

Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...

Aug 22, 20221 min read

USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Apr 17, 20222 min read

FDA's Bioavailability Guidance for NDAs or INDs- General consideration

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...